C3 President Speaks at NIH Meeting on Expansion of ClinicalTrials.Gov

Carlea Bauman, President of C3: Colorectal Cancer Coalition spoke today. April 20, 2009, at a public meeting called by the National Institutes of Health to hear input on expansion of its clinical trials registry.

In calling for the ClinicalTrials.Gov database to include results of all clinical trials, Bauman said,

C3:Colorectal Cancer Coalition is committed to providing results of clinical trials that affect patients with colon and rectal cancer fairly and honestly, providing both positive and negative conclusions, and helping patients to understand what the results mean to them in language they can understand.

Clinicaltrials.gov currently lists most Phase II and III clinical trials and some earlier Phase I trials. As of March 2009, it contained information about more than 69,000 clinical trials being conducted in over 160 countries. The Food and Drug Administration Amendments Act of 2007 (FDAAA) calls for expanding data included in the registry to include results of those trials.

In her remarks at the public meeting, Bauman stressed:

Having clear, understandable results of all clinical trials in a single, searchable place is critical to patient decision-making. Patients should be able to know what results of a clinical trial mean for them: what the benefits of a treatment are, what the side effects or other harms might be, and exactly which patients might be most helped or harmed.

Patients who contribute to medical research by volunteering to participate in clinical studies deserve to know the results of their involvement. Research has shown that they want this information.

All clinical research results — positive, negative, and inconclusive — should be easily available to patients and consumers.

A simple, but complete, description of the clinical trial design, its endpoints, and the statistical basis for determining whether or not endpoints were reached should be included with the results.

C3 will provide additional written comments to assist in the NIH rule-making to ensure that the needs of people affected by colon and rectal cancer are met with the expanded registry and database.

Comments

AS someone who has been a part of a clinical trial for stage 4 colerectal cancer.I agree that it would be helpful if individuals who have particpated in clinical trials should know what the results are or what information has been gained.It would be helpful when speaking to others who are thinking about being a part of one.